510(k) · Cleared
ClearedAnnalise Enterprise CXR Triage Pneumothorax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Annalise-Ai · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Feb 24, 2022 as substantially equivalent to K191556 (Behold.Ai Technologies Limited, 2020) after a 70-day review. Its family tree reaches back 4 generations to 2018. 3 later devices descend from it.
- Decided
- Feb 24, 2022
- Review
- 70 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 2 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 1 generation backK191556 Red DotBehold.Ai Technologies Limited · 2020
- This deviceK213941 Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022
- Descendant · cites it directly · 1 of its ownK222179 Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK250831 Annalise EnterpriseAnnalise-Ai · 2025
- Descendant · cites it directly · 0 of its ownK222268 Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −3 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −2 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| −1 | K191556 | Red Dot | Behold.Ai Technologies Limited | 2020 | — |
| 0 (this device) | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022 | — |
| +1 | K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
| +2 | K250831 | Annalise Enterprise | Annalise-Ai | 2025 | — |
| +1 | K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191556 | Red DotSummary page 4…ss II Product Code QFM III. PREDICATE DEVICE Manufacturer Name Behold.AI Technologies Limited Device Name Red Dot 510(k) reference K191556 Classification Name Radiological computer aided triage and notification software (21CFR892.2080) Reg… | 2020 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K222179 (Annalise-Ai Pty, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K191556.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The device is designed to aid the clinical assessment of adult chest x-ray cases with features suggestive of pneumothorax and tension pneumothorax in the medical care environment. The device analyses cases using an artificial intelligence algorithm to identify findings. It makes case-level output available to a PACS or RIS for worklist prioritization or triage. The device is intended to be used by trained clinicians who are qualified to interpret chest…
Read the full statement (136 words)
The device is designed to aid the clinical assessment of adult chest x-ray cases with features suggestive of pneumothorax and tension pneumothorax in the medical care environment. The device analyses cases using an artificial intelligence algorithm to identify findings. It makes case-level output available to a PACS or RIS for worklist prioritization or triage.
The device is intended to be used by trained clinicians who are qualified to interpret chest X-rays as part of their scope of practice. The device is not intended to direct attention to specific portions of an image or to anomalies other than pneumothorax and tension pneumothorax. Its results are not intended to be used on a standalone basis for clinical decision making nor it is intended to rule out pneumothorax or tension pneumothorax, or otherwise preclude clinical assessment of X-ray cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213941: Annalise Enterprise CXR Triage Pneumothorax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213941
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026